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510(k) Data Aggregation
K Number
K050388Device Name
REFIX INTERNAL FRACTURE FIXATION SCREWS
Manufacturer
Date Cleared
2005-09-07
(204 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
XTREMI-T, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing bone fragments.
For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.
Device Description
ReFIX™ Screws are comprised of Internal Fracture Fixation Devices based upon biodegradable polymer fixation systems. Biodegradable polymers are widely used in the orthopaedic specialty. The ReFIX Screws are manufactured from PLLA and PLGA. The Screws are available in diameters ranging from 2.7mm to 6.0mm. ReFIX Screws are available in lengths ranging from 30mm to 60mm. The Screws are sized and trimmed intraoperatively using the ReFIX instrumentation according to the surgical technique. The sizes and materials are designed to address the indications cited.
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K Number
K043339Device Name
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG
Manufacturer
Date Cleared
2005-04-18
(136 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
XTREMI-T, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
For example, ReFIX pins are intended for use in the following procedures:
- fixation of phalangeal fusion and fracture .
- repair of metacarpal fusion and fracture
- fixation of hand and wrist fractures .
- fixation of metatarsal osteotomies .
- correction of hallux valgus .
Device Description
Brief Description of Internal Fracture Fixation Devices based upon ReFIX™ Pins are comprised of themal Package Pakken Divers are widely used in the orthopaedic specialty. The ReFTX Pins are manufactured from PLLA and PLGA. The pins are available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, each supplied in a length of 70mm. The pins are sized and trimmed intraction and materials are de length of 70mm. The pins are sized and unimited misues and materials are designed to address the indications cited.
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